Erectile dysfunction is a serious condition which afflicts a significant percentage of the male population worldwide. This condition often has significant psychological effects which can, in severe cases, significantly reduce the quality of life for the person affected. The effects are often most severe among elderly male patients, but this condition has become increasingly prevalent within the middle-aged, and even the youthful segments of the male population.
It is believed that the parasympathetic nerve plays an important role in the regulation of erectile function. As noted above, impotence is most frequent in the elderly male population. Impotence is also a frequent affliction among male patients who have undergone prostatectomy, either for treatment of prostate cancer or an enlarged prostate condition. In fact, although numerous patients are candidates for removal of enlarged prostate, many elect not to have the surgery, and to live with the effects of an enlarged prostate, because they fear loss of normal erectile function. In addition to prostatectomy, several other causes have been linked to erectile dysfunction, including diabetes, psychological causes, surgery (including lower back which affects the parasympathetic nerve), trauma, obesity, smoking, or any other condition which constricts or restricts the arteries or reduces blood flow.
There are currently five methods available for treatment of erectile dysfunction. First, a prostaglandin-E1 product (Muse, Vivus) is available for intra urethral administration. Injectable products include products comprising prostaglandin-E1 for intramuscular/intracavernosal injection. None of these products interact with all of the important receptors or with the parasympathetic nerve. In fact, injectable products including only prostaglandin-E1 have been shown to have an efficacy of no greater than 50%. Moreover, none of these products have shown any efficacy for reversal of erectile dysfunction, and therefore injection or administration must be repeated each time an erection is desired. Further drawbacks of these injectable preparations are that they produce pain and unnatural erection, in addition to the difficulties of injection. In addition to these pharmaceutical treatments for erectile dysfunction, implants have also been used for treatment of erectile dysfunction. These include both permanently rigid implants (e.g., Erectaid), as well as implants having pumping capabilities, and which therefore can be deflated after use.
Thus, a product is needed for treatment of erectile dysfunction having an efficacy of greater than 50%. Moreover, a product is needed for reversal of erectile dysfunction, a product for which one or a few administrations will restore to the patient normal erectile function. Moreover, a pharmaceutical product is needed for treatment of impotence in male patients who have undergone prostatectomy, surgery (including lower back which affects the parasympathetic nerve), trauma, or who suffer from diabetes, psychological causes of impotence, obesity, smoking, or any other condition which constricts or restricts the arteries or reduces blood flow.